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Pharmaceuticals
Special Issues
Recent Advances in Manufacturing, Production, and Characterization of Antibody-Based Therapeutics
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Recent Advances in Manufacturing, Production, and Characterization of Antibody-Based Therapeutics

A special issue of Pharmaceuticals (ISSN 1424-8247). This special issue belongs to the section "Biopharmaceuticals".

Deadline for manuscript submissions: closed (28 February 2023) | Viewed by 7044

Special Issue Editor

Dr. Nishant Mohan

E-Mail Website
Guest Editor
Division of Biotechnology Review and Research 1, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993, USA
Interests: antibody; mab

Special Issue Information

Dear Colleagues,

Therapeutic monoclonal and bispecific antibodies have become some of the fastest growing emergent drugs, providing treatments for cancer, immunological, inflammatory disorders, and more recently, for COVID-19 disease. Recent research and technological innovations have significantly contributed towards the discovery, development, manufacturing, production, and characterization of these complex drug molecules. Novel antibody engineering technologies have enhanced therapeutic efficacy and minimized immunological side effects, which has led to faster commercialization of antibody-based therapeutics. The advent of bispecific antibodies has further revolutionized this research area in which numerous molecular formats, structural diversity, and related manufacturing and development processes have been continuously explored to target variety of antigens.

The aim of this Special Issue is to offer to our readers recent research and technological advances in the broad area of therapeutic antibodies, including drug design and discovery, development, manufacturing and production, mechanisms of action and characterization.

Dr. Nishant Mohan
Guest Editor

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmaceuticals is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2900 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • drug discovery
  • monoclonal antibodies
  • bispecific antibodies
  • biomolecules
  • manufacturing
  • antibody engineering
  • antibody production
  • antibody characterization
  • mechanism of action

Published Papers (1 paper)

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Review

30 pages, 679 KiB  
Review
Analytical Techniques for the Characterization and Quantification of Monoclonal Antibodies
by Hassan A. Alhazmi and Mohammed Albratty
Pharmaceuticals 2023, 16(2), 291; https://doi.org/10.3390/ph16020291 - 14 Feb 2023
Cited by 16 | Viewed by 6812
Abstract
Monoclonal antibodies (mAbs) are a fast-growing class of biopharmaceuticals. They are widely used in the identification and detection of cell makers, serum analytes, and pathogenic agents, and are remarkably used for the cure of autoimmune diseases, infectious diseases, or malignancies. The successful application [...] Read more.
Monoclonal antibodies (mAbs) are a fast-growing class of biopharmaceuticals. They are widely used in the identification and detection of cell makers, serum analytes, and pathogenic agents, and are remarkably used for the cure of autoimmune diseases, infectious diseases, or malignancies. The successful application of therapeutic mAbs is based on their ability to precisely interact with their appropriate target sites. The precision of mAbs rely on the isolation techniques delivering pure, consistent, stable, and safe lots that can be used for analytical, diagnostic, or therapeutic applications. During the creation of a biologic, the key quality features of a particular mAb, such as structure, post-translational modifications, and activities at the biomolecular and cellular levels, must be characterized and profiled in great detail. This implies the requirement of powerful state of the art analytical techniques for quality control and characterization of mAbs. Until now, various analytical techniques have been developed to characterize and quantify the mAbs according to the regulatory guidelines. The present review summarizes the major techniques used for the analyses of mAbs which include chromatographic, electrophoretic, spectroscopic, and electrochemical methods in addition to the modifications in these methods for improving the quality of mAbs. This compilation of major analytical techniques will help students and researchers to have an overview of the methodologies employed by the biopharmaceutical industry for structural characterization of mAbs for eventual release of therapeutics in the drug market. Full article
(This article belongs to the Special Issue Recent Advances in Manufacturing, Production, and Characterization of Antibody-Based Therapeutics)
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